Opioid Analgesic Reduction Study (OARS) - Pilot

Phase 3

Completed

Conditions: Post Operative Pain

Interventions: Drug: OPIOID
Drug: NON-OPIOID

Registration Number: NCT05283499

Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary: The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.

Detailed Description: A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

Inclusion Criteria

Adult men and non-pregnant women who are at least 18 years of age, who are able to refrain from driving or operating heavy machinery while taking the study medication will be able to participate.
Subjects who are English speaking and are able to provide consent will be considered.
Subjects must be in generally good health and able to take ibuprofen, paracetamol (acetaminophen), and hydrocodone.

Exclusion Criteria

Subjects who self-report the following history will be excluded from participating:

Individual under the age of 18
History of gastrointestinal bleeding and/or peptic ulcer
History of renal disease (excluding kidney stones)
History of hepatic disease
History of bleeding disorder
History of respiratory depression
Any prior respiratory effect of an opioid or other anesthetic drug that required respiratory support postoperatively
Active or untreated asthma
History of known allergic reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia
Currently taking any of the following medications:
- CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression
- CNS depressants.
Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism
History of drug or alcohol abuse (excludes marijuana use)
Family history of drug or alcohol abuse in a first degree relative
Has had one or more opioid prescription filled within the past 6 months
Currently pregnant or lactating

Patients would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:

Prior participation in this study
Inability or refusal to provide informed consent

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid	OPIOID	Combination analgesic of hydrocodone 5mg/acetaminophen350 mg
Non-Opioid	NON-OPIOID	Combination analgesic of ibuprofen 400mgacademinophen 350mg

Primary Outcome Measures

Name	Time	Method
Pain Level	Average for the first seven days post surgery	Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain

Secondary Outcome Measures

Name	Time	Method
Sleep Quality	Average for the first seven nights post surgery	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	Average for the first seven days post surgery	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Overall Satisfaction	Average for the first seven days post surgery	Subject's rating of overall satisfaction with the analgesic provided after surgery on a 5 point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied)

Trial Locations

Locations (5): University of Rochester
🇺🇸
Rochester, New York, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
University of Illinois Chicago
🇺🇸
Chicago, Illinois, United States
University of Maryland
🇺🇸
Baltimore, Maryland, United States
Rutgers University
🇺🇸
Newark, New Jersey, United States